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NCT06517810 · ClinicalTrials.gov registry record
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
A clinical trial of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, sponsored by SeaStar Medical.
- Recruiting
- Registry status
- 300
- Enrollment target
- 15
- Study locations
NCT06517810 is a study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis that is actively recruiting participants, run by SeaStar Medical. The registered enrollment target is 300 participants, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower). The trial reports 15 study locations across 10 states.
The verdict
NCT06517810, a study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, is actively recruiting participants, sponsored by SeaStar Medical.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 15
- Study locations
Study Summary
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
Conditions Studied
Interventions
- DEVICE QUELIMMUNE (SCD-PED)
Study Locations (15)
Texas
- Children's Medical Center Dallas - Dallas
- Cook Children's Hospital - Fort Worth
- Texas Children's Hospital - Houston
California
- Lucile Packard Children's Hospital Stanford - Palo Alto
- UCSF Benioff Children's - San Francisco
Georgia
- Children's Hospital of Atlanta - Arthur M. Blank - Atlanta
- Children's Hospital of Atlanta - Scottish Rite - Atlanta
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Cleveland Clinic Children's Hospital - Cleveland
Alabama
- Children's of Alabama - Birmingham
Colorado
- HealthONE HCA Rocky Mountain Children's Hospital - Denver
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Michigan
- CS Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2026-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06517810
The ClinicalTrials.gov registry entry for NCT06517810 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower). The listed sponsor is SeaStar Medical, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention - of which QUELIMMUNE (SCD-PED) is the first listed.
NCT06517810 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Texas, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06517810 about?
NCT06517810 is a clinical study titled "QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry". QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients...
What is the current status of trial NCT06517810?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2024-07-19. Estimated completion is 2026-05.
What conditions does trial NCT06517810 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Acute Kidney Injury Due to Sepsis.
What interventions are being tested in trial NCT06517810?
The interventions under investigation include: QUELIMMUNE (SCD-PED) (DEVICE).
Who is sponsoring clinical trial NCT06517810?
This trial is sponsored by SeaStar Medical, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06517810 being conducted?
This trial has 15 study locations across Alabama, California, Colorado, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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